In the US, and most other industrial countries, pharmaceuticals are strictly regulated by government agencies such as the US Food and Drug Administration (FDA). Part of this regulation requires that pharmaceutical and medical companies conduct extensive clinical research in order to demonstrate the safety and efficacy of new drugs and devices before they can be approved for commercial use.
These clinical trials are typically costly and time consuming and usually involve significant amounts of data. In order to speed up, and reduce the cost of, clinical trials and their evaluation, the FDA is attempting to implement standardization of the data that is electronically submitted to them as regulatory submissions for evaluation.
In particular, they are attempting to standardize on the Clinical Data Interchange Standards Consortium (CDISC)'s Study Data Tabulation Model (SDTM).
A problem facing the pharmaceutical and medical industry is that currently clinical, non-clinical, lab and healthcare data exists in multiple physical formats, with datasets typically having heterogeneous syntax and semantics. The data may also be located across multiple geographical locations and organizations, and may exist at different stage of the clinical research life cycle. All of these factors make it difficult to assemble and aggregate such data for regulatory submissions.